Sr. Clinical Research Associate (Remote)

Job Description SummaryThe Senior Clinical Research Associate is responsible for delivering high quality and compliant site management and monitoring for clinical studies sponsored by the BD Peripheral Intervention business unit, ensuring scientific quality, integrity, and ethics in accordance with BD global clinical procedures, study protocols, GCP, and applicable regulations. The role includes day-to-day management and oversight of assigned clinical sites, on-site and remote monitoring, recruitment support, technical/troubleshooting assistance, and building strong relationships with site personnel. It also involves leading or supporting Clinical Project Management activities including study development, start-up, conduct/maintenance, and close-out, along with reviewing and developing essential clinical study documents.Education and experience details are provided in the sections below.Job ResponsibilitiesProvide site management and monitoring support for BD Peripheral Intervention studies to enable successful completion of study objectives and deliverables.Ensure quality and compliance for assigned clinical studies and activities at clinical sites, adhering to BD global clinical procedures, study protocols, GCP, and applicable regulations.Conduct on-site or remote monitoring activities to evaluate site qualification/activation, review informed consent forms, verify data accuracy, address data queries, ensure compliant study conduct, address non-compliance, implement corrective actions, perform investigational product accountability, ensure regulatory approvals, and review essential study documents.Serve as a product, procedure, and clinical study protocol expert for BD stakeholders and site personnel.Develop and maintain relationships with investigational site staff and cross-functional teams; facilitate communication between sites and BD stakeholders.Develop and manage study-specific tracking reports (e.g., screening/enrollment, site activation, SDV status) to ensure compliant deliverables within timelines and budgets.Perform TMF audits for accuracy and audit-readiness; assist with CTMS maintenance to ensure current and complete study and site details.Prepare study-specific reports and other essential clinical study documents (e.g., activation checklists, visit reports, training logs, logs, and management forms).Review and provide input on development of documents related to Clinical Project Management, Clinical Data Management, Clinical Statistics, Clinical Safety Management, Clinical Product Management, and Clinical Supplier Management.Identify opportunities to enhance overall study performance and provide input to cross-functional municate product complaints and other events that affect safety or study performance to BD stakeholders in accordance with procedures.Participate in, support, and/or lead study-specific meetings (e.g., study teams, CRA team meetings, vendor meetings).Support Clinical Project Management with administrative tasks to facilitate study conduct.Provide critical thinking and issue escalation support for site management and monitoring; collaborate with sites, vendors, and functional areas to mitigate issues.Support internal or external audits/inspections and ensure resolution of findings related to site management and monitoring activities.Support continuous improvement initiatives and development of site management and monitoring tools.Mentor Site Management & Monitoring personnel and conduct monitoring evaluations or co-monitoring visits; identify performance issues and training opportunities and communicate with leadership.Education and ExperienceBachelor's Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)5+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)4+ years of experience with site management & monitoring or managing clinical projectsKnowledge, Skills and QualificationsStrong working knowledge of domestic and international clinical research regulations and GCP.Proficiency with Microsoft Office tools (Outlook, Word, Excel, PowerPoint, OneNote, SharePoint, etc.).Proficient knowledge of clinical study processes and systems (eTMF, CTMS, CDMS).Strong interpersonal and communication/presentation skills (oral and written).Strong organizational skills, attention to detail, judgment, and analytical ability.Ability to manage and delegate multiple tasks and prioritize effectively.Ability to travel up to 60% (or more during peak times).Preferred Skills & ExperiencePrior experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease, and/or oncology.Experience with medical device studies.Proficiency with Veeva Vault CTMS, CDMS, and eTMF.Professional certification through associations such as ACRP or SOCRA.Physical DemandsRegularly required to stand, walk, sit, use sight, and manipulate objects; frequent verbal communication with colleagues; occasional reaching, bending, kneeling, or crouching.Work EnvironmentOpen-cubicle environment; teamwork-oriented, fast-paced setting. BD is an equal opportunity employer that values diversity.On-site collaboration is prioritized; minimum in-office presence requirements may apply by role. Remote or field-based positions will have arrangements noted in the job posting.Equal Opportunity StatementBecton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation or gender identity, genetics, disability, military status, or other legally protected characteristics. #J-18808-Ljbffr

Created: 2026-04-21